Baldness Med Carries New Sexual Side Effects Warning

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Changes to the labeling of the popular baldness medication Propecia and prostate medication Proscar was issued by the U.S. Food and Drug Administration (FDA) recently to alert users of the drugs about the possibility of experiencing sexual side effects during and after discontinuing use of the medications.

The causative link between both drugs is the active ingredient finasteride that belongs to a class of prescription medicines called 5 alpha-reductase inhibitors, which have some proven ability in treating male pattern baldness and patients with benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is a common problem among older men characterized by an enlarged prostate gland, lower urinary tract symptoms, and decreased flow of urine. It is a progressive disease that can lead to complications such as acute urinary retention (AUR) or a need for enlarged prostate surgery in some men. Dihydrotestosterone is the primary androgen involved in both normal and abnormal prostate growth and 5α-reductase inhibitors work by inhibiting the conversion of testosterone to dihydrotestosterone.

The revision to the Propecia label includes warnings of:

• Libido disorders
• Ejaculation problems
• Orgasm difficulties

The revision to the Proscar label includes a decrease in libido that continues after discontinuation of the drug.

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The risk of experiencing sexual side effects from either drug is very low. Clinical trials have shown that during treatment with a finasteride-containing drug such as Propecia, that 36 (3.8%) out of 945 men had reported one or more adverse sexual experiences as compared to 20 (2.1%) out of 934 men who received a placebo.

The label change for Propecia was motivated by 421 reports of sexual dysfunction between 1998 and 2011 of which 59 cases reported sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders.

The label change for Proscar resulted from an FDA review of 131 cases of erectile dysfunction and 68 cases of decreased libido associated with the use of finasteride at the 5 mg dosage between 1992 and 2010. In some cases, reported events of erectile dysfunction and decreased libido lasted for at least several weeks after drug use was discontinued.

However, in spite of the changes to the labeling of the two medications the FDA states that clear causal links between Propecia and Proscar with sexual adverse events have NOT been established, and that the change in labeling may be important to individual patients rather than the user population in whole. The FDA believes that the labeling change is information that prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of taking a finasteride-based medication when determining the best treatment options.

One example is the use of Propecia which is used primarily by younger, reproductive-age males who are beginning to discover that they are developing male pattern baldness. This possibility of sexual side effects such as a decrease in semen quality or difficulty with libido or ejaculation at a time when they may be attempting to conceive would necessitate other options with their physician.

The FDA recommends that patients and physicians should report adverse events experienced with either Propecia or Proscar to the FDA MedWatch program. MedWatch is available by phone at 1-800-332-1088, or you can report online at MedWatch Online1, or submit your report using regular mail and postage-paid FDA Form 35002.

Image Source: Courtesy of Wikipedia

Reference: US Food and Drug Administration

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